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FDA 510(k)

OSOM CARD II HCG-URINE TEST, MODEL 102

K-Number: K990578 · 1999-03-09

ApplicantWyntek Diagnostics, Inc.
Decision Date1999-03-09
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSOM CARD II HCG-URINE TEST, MODEL 102 is the device name listed in this FDA 510(k) record. The listed applicant is Wyntek Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-03-09 under 510(k) number K990578. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM CARD II HCG-URINE TEST, MODEL 102?

OSOM CARD II HCG-URINE TEST, MODEL 102 is a medical device that received FDA 510(k) clearance on 1999-03-09. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K990578.

When did OSOM CARD II HCG-URINE TEST, MODEL 102 receive FDA 510(k) clearance?

OSOM CARD II HCG-URINE TEST, MODEL 102 received FDA 510(k) clearance on 1999-03-09, under 510(k) number K990578.

Who is the listed applicant for OSOM CARD II HCG-URINE TEST, MODEL 102?

The FDA 510(k) record lists Wyntek Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSOM CARD II HCG-URINE TEST, MODEL 102?

The FDA product code for OSOM CARD II HCG-URINE TEST, MODEL 102 is JHI.

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Other records listing Wyntek Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992658OSOM ULTRA STREP A TEST, MODEL 147K990576OSOM CARD PREGNANCY TEST, MODEL 103K974159OSOM HCG-URINE TEST MODEL 101K973879OSOM CARD HCG-URINE TESTK972231OSOM MONO TEST 143K965184PERFECTA PREGNANCY TEST

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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